TightRail Rotating Dilator Sheath 545-513 (UDI 00813132021658)Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00813132021658), received between Jul 23, 2019 and Sep 29, 2026 — classified as 20 deaths, 44 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Entrapment of Device

  A lead extraction procedure commenced to remove a right ventricular (RV) and right atrial (RA) lead due to CIED System/Pocket Infection. Spectranetics LLD EZ Lead Locking Devices (LLD EZs) were inserted into each lead to provide traction. Beginning with a Spectranetics 13F TightRail Rotating Dilator Sheath on the RV lead, the TightRail became stuck on the lead and LLD EZ, requiring intervention by cutting the RV lead and LLD EZ (MDR #3007284006-2026-00459). Therefore, the RV lead and LLD EZ remnant remained in the patient (3007284006-2026-00463). The extraction procedure continued, a new TightRail was used, and the RA lead was successfully removed. The patient survived the procedure.This report captures the 13F TightRail that entrapped the lead and LLD, requiring intervention.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937831 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove two right ventricular (RV), a right atrial (RA), and a left ventricular (LV) lead due to bacteremia. Spectranetics LLD Lead Locking Devices (LLDs) were inserted into each lead to provide traction. Beginning with a 14F GlideLight Laser Sheath, the LV and one RV lead were successfully removed. Next, the RA lead and remaining RV lead were targeted with a Spectranetics 13F TightRail Rotating Dilator Sheath. However, once the RV lead was removed and the TightRail came out of the body, the patient's blood pressure dropped, and rescue efforts began, including pericardiocentesis and sternotomy. A superior vena cava (SVC) perforation was discovered, and repaired, and the RA lead was removed post-sternotomy. The patient survived the procedure. This report captures the TightRail in use when the perforation occurred, requiring intervention. There was no alleged malfunction of any Spectranetics devices in use during the procedure.

  Patient problems: Great Vessel Perforation

  MAUDE report 50506809 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Perforation of Vessels

  MAUDE report 50224395 ↗
• DeathAug 12, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove a right atrial (RA), right ventricular (RV), and left ventricular (LV) leads due to bacteremia. Spectranetics LLD EZ Lead Locking Devices (LLD EZs) were inserted into each lead to provide traction. Beginning with multiple Spectranetics devices (11F TightRail Sub-C Rotating Dilator Sheath, 11F TightRail Rotation Dilator Sheath (long), and 14F GlideLight Laser Sheath) on the RV lead, resistance was met under the clavicle with lead on lead binding. Upon reaching the innominate/superior vena cava (SVC) junction, the decision was made to switch the RA lead; however, encountered the same binding. Utilizing a Spectranetics 13F TightRail Rotating Dilator Sheath, advancement was made down to the SVC/RA junction, when the RA lead came free. A pericardial effusion was detected via intracardiac echocardiography (ICE), and rescue efforts began, including rescue balloon, pericardiocentesis, CPR, and sternotomy. A large SVC perforation was discovered, but was unable to be repaired, and the patient did not survive the procedure.This report captures the TightRail in use when the perforation occurred, requiring intervention, but resulting in death. The

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 50221186 ↗
• DeathMar 25, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV) LEADS (ONE PACING AND ONE ICD) DUE TO NON-FUNCTION. A RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS WERE PRESENT WITHIN THE PATIENT BUT NOT TARGETED FOR EXTRACTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SHOCKWAVE MEDICAL BALLOON, LARGE AMOUNTS OF AIR WAS OBSERVED, ALONG WITH FAULT CODES, SO ANOTHER BALLOON WAS USED THROUGHOUT THE INNOMINATE AND SUPERIOR VENA CAVA (SVC) WITH NO ISSUE. THEN, UTILIZING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, THE RV PACING LEAD WAS REMOVED. NEXT, USING A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ALONG WITH A SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH, LITTLE FORWARD PROGRESS WAS MADE SO SWITCHED TO A SPECTRANETICS 13F TIGHTRAIL SUB-C. ALMOST REACHING THE SVC, THE SAME 16F GLIDELIGHT WAS USED AGAIN, WITH SLOW ADVANCEMENT THROUGH THE INNOMINATE TO THE SVC. AT THE MID SVC, THE RV ICD LEAD, ALONG WITH THE LLD EZ BROKE (MDR #3007284006-2026-00101), AND THE DECISION WAS MADE TO SWITCH TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR S

  Patient problems: Great Vessel Perforation; Perforation of Vessels

  MAUDE report 24690906 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO BACTEREMIA. SPECTRANETICS LLD #2 LEAD LOCKING DEVICES (LLD #2S) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH ON THE RV LEAD, PROGRESS STALLED WITHIN THE SUBCLAVIAN REGION, AND THE PATIENT'S BLOOD PRESSURE DROPPED. A PERFORATION TO THE AXILLARY VEIN WAS DISCOVERED, AND RESCUE EFFORTS BEGAN, INCLUDING EXPANDING THE POCKET IN ORDER TO REPAIR THE PERFORATION. THE PATIENT STABILIZED, AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER PATIENT HARM. THIS REPORT CAPTURES THE TIGHTRAIL IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 24598013 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE 3 RIGHT VENTRICULAR (RV) AND 2 RIGHT ATRIAL (RA) LEADS DUE TO NON-FUNCTION AND MRI. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, MINIMAL ADVANCEMENT WAS MADE; THEREFORE, SWITCHED TO A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH. ALTERNATING BETWEEN LEADS, LITTLE PROGRESS WAS MADE, AND SWITCHED TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ALONG WITH A SPECTRANETICS LARGE VISISHEATH. THEN, UTILIZING A SPECTRANETICS 13F TIGHTRAIL (LONG) ROTATING DILATOR SHEATH IN HEAVY CALCIFICATION, THE BLADES WOULD NO LONGER ROTATE. A SECOND 13F TIGHTRAIL (LONG) WAS USED, AND ONE RV AND ONE RA LEAD WERE REMOVED. WHEN TRYING TO LOAD THE SAME 13F TIGHTRAIL (LONG) ONTO THE NEXT RV LEAD AND LLD EZ, THE INSIDE OF THE TIGHTRAIL PUSHED OUT THE BACK. A THIRD 13F TIGHTRAIL (LONG) WAS USED, BUT THE SAME ISSUE OCCURRED, AND A FOURTH 13F TIGHTRAIL (LONG) WAS UTILIZED, BUT GOT STUCK ON THE RV LEAD, AND WHEN REMOVING THE 13F TIGHTRAIL (LONG) FROM THE BODY, THE INSIDE CAME OUT AGAIN, THUS WAS REMOVED FROM THE PATIENT. S

  Patient problems: Perforation of Vessels

  MAUDE report 24305745 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO MRI AND NON-FUNCTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, THE RA LEAD WAS SUCCESSFULLY REMOVED. HOWEVER, WHEN REMOVING THE RV LEAD, A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. A PERFORATION EXTENDING FROM THE INNOMINATE TO THE SUPERIOR VENA CAVA (SVC) AND INTO THE RIGHT ATRIUM WAS DISCOVERED AND REPAIRED. THE DECISION WAS MADE TO ABANDON THE EXTRACTION; THEREFORE, THE LLD EZ, ALONG WITH THE RV LEAD, WERE CUT AND CAPPED AND REMAINED IN THE PATIENT (MDR #3007284006-2026-00039). THERE WAS NO ATTEMPT MADE TO UNLOCK THE LLD EZ. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Perforation of Vessels; Pericardial Effusion

  MAUDE report 24264141 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. A RIGHT ATRIAL (RA) LEAD WAS PRESENT WITHIN THE PATIENT, BUT NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT, DENSE BINDING IN THE INNOMINATE WAS ENCOUNTERED. THEN, SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, ADVANCEMENT WAS MADE TO THE SUPERIOR VENA CAVA (SVC)/INNOMINATE JUNCTION, WHEN THE LEAD BROKE. ADVANCEMENT CONTINUED DOWN THE SVC/RA JUNCTION, BUT BINDING WAS ENCOUNTERED AGAIN. WHEN REMOVING THE TIGHTRAIL FROM THE PATIENT, THE BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS AND STERNOTOMY. AN SVC/RA JUNCTION PERFORATION WAS DISCOVERED AND REPAIRED. THE LLD EZ WAS REMOVED FROM THE RV LEAD, AND THE LEAD WAS CUT AND CAPPED AND REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE T

  Patient problems: Cardiac Perforation; Great Vessel Perforation; Pericardial Effusion

  MAUDE report 22806171 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO FRACTURE. A RIGHT ATRIAL (RA) LEAD WAS PRESENT, BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ADVANCEMENT PAST THE SUBCLAVIAN INTO THE INNOMINATE WAS UNSUCCESSFUL DUE TO CALCIFICATION. SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, PROGRESS WAS MADE THROUGH THE CLAVICLE AND INTO THE SUPERIOR VENA CAVA (SVC), BUT THEN STALLED. THE DECISION WAS MADE TO REMOVE THE RA LEAD AS A RESULT OF THE CALCIFICATION, SO THE TIGHTRAIL WAS REMOVED FROM THE BODY. UPON REMOVAL, THERE WAS A SUDDEN DROP IN BLOOD PRESSURE, AND A PERICARDIAL EFFUSION WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. PERFORATIONS IN THE INNOMINATE VEIN AND THE SVC WERE DISCOVERED AND REPAIRED. THE RV AND RA LEADS WERE REMOVED POST-STERNOTOMY, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL IN USE WHEN THE PERFORATIONS OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDU

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 22742996 ↗
• DeathJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO FRACTURE. A RIGHT ATRIAL (RA), LEFT VENTRICULAR (LV), AND A CAPPED RV LEAD WERE PRESENT IN THE PATIENT, BUT NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, SOME RESISTANCE WAS ENCOUNTERED; THEREFORE, A COOK MEDICAL INTRODUCER SHEATH WAS USED. THE LEAD CAME FREE FROM THE WALL OF THE RV AND A MERIT MEDICAL EN SNARE DEVICE WAS USED TO REPOSITION THE LEAD TO IMPROVE ALIGNMENT AND TRACTION. FURTHER RESISTANCE WAS MET AT THE COIL OF THE LEAD, AND UPSIZED TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH. AFTER NO FURTHER ADVANCEMENT COULD BE MADE, THE COOK MEDICAL INTRODUCER SHEATH WAS LOADED ONTO THE TIGHTRAIL. WITH SOME DIFFICULTY GOING AROUND THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION, THE TIGHTRAIL MOVED FURTHER ALONG THE LEAD PAST THE SVC, WHEN PROGRESS STALLED. UPON REMOVAL OF THE TIGHTRAIL, A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), AND RESCUE EFFORTS BEGAN, INCLUDING BYPASS AND STERNOTOMY. A SVC PERFORATION

  Patient problems: Cardiac Perforation; Great Vessel Perforation; Pericardial Effusion

  MAUDE report 22677767 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND TWO (ONE CAPPED AND ONE ACTIVE) RIGHT ATRIAL (RA) LEADS DUE TO CIED SYSTEM/POCKET INFECTION. IN A PREVIOUS EXTRACTION OF THE RA LEAD, ATTEMPTS WERE UNSUCCESSFUL, THUS THE LEAD WAS CUT AND CAPPED, AND A NEW ATRIAL LEAD WAS IMPLANTED. A SPECTRANETICS LLD #2 LEAD LOCKING DEVICE (LLD #2) WAS INSERTED INTO THE ACTIVE RA LEAD, AND SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO THE CAPPED RA AND RV LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 9F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH ON THE ACTIVE RA LEAD, HEAVY FIBROSIS AND LEAD ON LEAD BINDING TO THE CAPPED RA LEAD WAS ENCOUNTERED. THE ACTIVE RA LEAD WAS REMOVED, AND SWITCHED TO A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH (LONG) ON THE RV LEAD. HOWEVER, THE RV LEAD WAS CALCIFIED TO THE CAPPED RA LEAD, SO UPSIZED TO A 13F TIGHTRAIL (LONG). AFTER SOME TIME, THE CALCIFICATION WAS REMOVED, AND THE RV LEAD WAS EXTRACTED. CONTINUING WITH THE 13F TIGHTRAIL WITH SOME DIFFICULTY, THE CAPPED RA LEAD WAS EVENTUALLY REMOVED, BUT THE PATIENT¿S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, PERICARDIOCEN

  Patient problems: Cardiac Perforation; Great Vessel Perforation

  MAUDE report 22553186 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA), TWO RIGHT VENTRICULAR (RV), AND A LEFT VENTRICULAR (LV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION AND BACTEREMIA. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLD) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. USING A SPECTRANETICS GLIDELIGHT LASER SHEATH AND SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, THE RA, LV, AND ONE RV LEAD WERE REMOVED SUCCESSFULLY. AFTER REMOVAL OF THE FINAL RV LEAD, THE PATIENT'S BLOOD PRESSURE DROPPED, AND A SUBSTANTIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON, CPR, PERICARDIOCENTESIS, STERNOTOMY AND BYPASS. THE BLEEDING HAD SUBSIDED; HOWEVER, AN RV PERFORATION WAS DISCOVERED, BUT HAD CLOTTED OFF, AND THE INJURY WAS REPAIRED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL, THE LAST DEVICE IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 22539893 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO BACTEREMIA WITH MULTIPLE VEGETATIONS. PRIOR TO USE OF ANY SPECTRANETICS DEVICES, THE VEGETATIONS WERE REMOVED USING ANGIODYNAMICS-THE ANGIOVAC SYSTEM. THEN, SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. NEXT, A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED ON THE RV LEAD, AND LEAD WAS REMOVED SUCCESSFULLY. SWITCHING TO A NEW 13F TIGHTRAIL ON THE RA LEAD, THE LEAD WAS REMOVED, AND NO EFFUSIONS WERE DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). HOWEVER, AFTER SEVERAL MINUTES, THE PATIENT¿S BLOOD PRESSURE BEGAN TO DECLINE, AND A HEMOTHORAX WAS NOTED. RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY, AND A PERFORATION IN THE SUPERIOR VENA CAVA (SVC) WAS DISCOVERED AND REPAIRED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL DEVICE IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Hemothorax

  MAUDE report 22396200 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO MRI AND NON-FUNCTION. A RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) WERE PRESENT WITHIN THE PATIENT, BUT NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT, PROGRESS WAS MADE TO THE PROXIMAL COIL OF THE LEAD. THEN, SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, ADVANCEMENT WAS MADE OVER THE PROXIMAL COIL, WHEN THE PATIENT¿S BLOOD PRESSURE DROPPED. TRACTION ON THE LLD EZ WAS RELEASED, AND THE PATIENT STABILIZED. NEXT, THE TIGHTRAIL ADVANCED TO THE DISTAL COIL, BUT COULD NOT PROGRESS FURTHER DUE TO THE STIFFNESS OF THE OUTER SHEATH. WHEN REMOVING THE TIGHTRAIL FROM THE PATIENT TO ELIMINATE THE OUTER SHEATH, THE BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING CPR AND THE USE OF A SPECTRANETICS BRIDGE OCCLUDING BALLOON. THE BALLOON WAS ADVANCED UP THE GUIDEWIRE BUT WOULD NOT ADVANCE PAST THE IVC (MDR#: 3007284006-2025-00107). USE OF THE BRIDGE WAS ABANDONED, STERNOTOMY WA

  Patient problems: Cardiac Perforation; Great Vessel Perforation; Pericardial Effusion

  MAUDE report 22108021 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO REDUNDANCY. SPECTRANETICS LLD #2 LEAD LOCKING DEVICES (LLD #2S) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS GLIDELIGHT LASER SHEATH ON BOTH LEADS, LITTLE PROGRESS WAS MADE DUE TO HEAVY CALCIFICATION. SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH ON THE RA LEAD, ADVANCEMENT WAS MADE THROUGH THE SUPERIOR VENA CAVA (SVC). A PLEURAL EFFUSION WAS DETECTED VIA VENOGRAM, AND A SUBCLAVIAN PERFORATION WAS NOTED (MDR #3007284006-2025-00077). RESCUE EFFORTS BEGAN, AND THE TIGHTRAIL DEVICE WAS USED TO STOP BLEEDING FROM THE PERFORATION. A RESCUE BALLOON WAS USED TO TAMPONADE THE INJURY, AND A CHEST DRAIN WAS PLACED TO REMOVE THE BLOOD. THE PATIENT STABILIZED, AND VENOGRAM SHOWED NO EFFUSION, BUT MINIMAL BLOOD LOSS WAS COMING FROM THE CHEST TUBE. AS A RESULT, THE DECISION WAS MADE TO STOP THE EXTRACTION. NO ATTEMPT WAS MADE TO UNLOCK THE LLDS FROM THE RV LEAD, (MDR #3007284006-2025-00078), OR THE RA LEAD (MDR #3007284006-2025-00079), SO THE LEADS, ALONG WITH THE LLDS, WERE CUT AND CAPPED AND REMAINED IN THE PATIENT. THE PATIENT SU

  Patient problems: Perforation of Vessels

  MAUDE report 21894259 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD DUE TO BACTEREMIA. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH ON THE RA LEAD, PROGRESS WAS MADE THROUGH THE SCARRING IN THE POCKET. THEN, SWITCHING TO A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH, ADVANCEMENT WAS MADE TO THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION, WHERE PROGRESS STALLED. NEXT, THE RV LEAD WAS TARGETED; HOWEVER, PROGRESS STALLED AT THE SAME AREA; THEREFORE, SWITCHED TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH (LONG), BUT NO FURTHER MOVEMENT. USING A COOK MEDICAL 13F EVOLUTION, ADVANCEMENT WAS MADE PAST THE AREA, AND THE RV LEAD WAS REMOVED. FOCUSING ON THE RA LEAD, WITH THE 13F TIGHTRAIL, PROGRESS WAS MADE TO THE TIP OF THE LEAD, AND WITH TRACTION, THE LEAD RELEASED. THE TIGHTRAIL WAS REMOVED BUT THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, CPR, AND STERNOTOMY. A SMALL SVC/RA JUNCTION PERFORATION WAS DISCOVERED AND REPAIR

  Patient problems: Cardiac Perforation; Great Vessel Perforation

  MAUDE report 21721864 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH ON THE RV LEAD, ADVANCEMENT WAS MADE TO THE INNOMINATE, WHERE SNOWPLOWING OF THE LEAD OCCURRED. THEN, SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, PROGRESS WAS MADE TO THE TRICUSPID VALVE; HOWEVER THE PATIENT'S BLOOD PRESSURE DROPPED, AND AN EFFUSION WAS SEEN VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS AND STERNOTOMY. A PERFORATION FROM THE SUPERIOR VENA CAVA (SVC)/INNOMINATE JUNCTION INTO THE SVC WAS DISCOVERED AND REPAIRED. THE RA AND RV LEADS WERE REMOVED POST-STERNOTOMY, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL IN USE IN THE AREA WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Perforation of Vessels; Pericardial Effusion

  MAUDE report 21638594 ↗
• DeathFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD, A RIGHT ATRIAL (RA) LEAD, AND A LEFT VENTRICULAR (LV) LEAD DUE TO BACTEREMIA. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH OF THE LEADS TO PROVIDE TRACTION. USING A SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, SPECTRANETICS GLIDELIGHT LASER SHEATH, AND 13F TIGHTRAIL (LONG), THE RV AND RA LEADS WERE REMOVED SUCCESSFULLY. THEN, THE 13F TIGHTRAIL (LONG) WAS USED ON THE LV LEAD AND ADVANCEMENT WAS MADE DOWN TO THE CORONARY SINUS (CS) OSTIUM, WHERE TRACTION WAS APPLIED, AND THE LV LEAD WAS EXTRACTED. HOWEVER, AN EFFUSION WAS NOTED, AND RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS AND STERNOTOMY. A CS PERFORATION WAS DISCOVERED, BUT UNABLE TO BE REPAIRED, AND THE PATIENT DID NOT SURVIVE. THIS REPORT CAPTURES THE 13F TIGHTRAIL IN USE IN THE AREA WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION BUT RESULTING IN DEATH. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 21472290 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD AND A RIGHT ATRIAL (RA) LEAD DUE TO BACTEREMIA. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS GLIDELIGHT LASER SHEATH AND A SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, WHILE SWITCHING BACK AND FORTH ON BOTH LEADS, PROGRESS STALLED. THEN, USING A SPECTRANETICS 13F TIGHTRAIL ROTATION DILATOR SHEATH ON THE RV LEAD, ADVANCEMENT WAS MADE JUST BEFORE THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION, WHEN THE PATIENT¿S BLOOD PRESSURE DROPPED, AND EFFUSION WAS DETECTED VIA TEE. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, CPR, SUBXIPHOID WINDOW, AND STERNOTOMY. AN SVC/RA JUNCTION PERFORATION WAS DISCOVERED AND REPAIRED. BOTH RV AND RA LEADS WERE REMOVED POST-STERNOTOMY, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation; Great Vessel Perforation; Pericardial Effusion

  MAUDE report 21358976 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD AND A RIGHT ATRIAL LEAD (RA) DUE TO BACTEREMIA AND NON-FUNCTION. THE PROCEDURE STARTED WITH A STERNOTOMY TO AID IN THE REMOVAL OF BACTERIAL VEGETATION AND A TRICUSPID VALVE REPAIR. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. WHILE USING A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH (LONG) ON THE RV LEAD, SIGNIFICANT BLOOD LOSS WAS OBSERVED. A SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED, AND RESCUE EFFORTS BEGAN. THE PERFORATION WAS SUCCESSFULLY OCCLUDED, LLD EZS WERE REMOVED, AND THE LEADS WERE CUT AND REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation

  MAUDE report 21358657 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV, ONE ACTIVE AND ONE CAPPED) LEADS, AND A RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE ACTIVE RV LEAD TO PROVIDE TRACTION. THE PROCEDURE BEGAN BY USING A SHOCKWAVE MEDICAL BALLOON TO BREAK UP CALCIUM WITHIN THE SUPERIOR VENA CAVA (SVC) AND WAS REMOVED. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH, ADVANCEMENT WAS MADE TO THE SVC, WHERE PROGRESS STALLED. SWITCHING TO A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH (LONG), ADVANCEMENT WAS MADE THROUGH THE SVC. THEN, THE 14F GLIDELIGHT AND VISISHEATH WERE USED AGAIN, BUT NO FURTHER PROGRESS WAS MADE. UPSIZING TO A 16F GLIDELIGHT AND VISISHEATH, ONLY SLIGHT PROGRESS WAS ACHIEVED; THEREFORE, A 13F TIGHT RAIL WAS USED, REACHING THE TIP OF THE RV LEAD, AND THE LEAD WAS EXTRACTED. HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED, BUT NO EFFUSION WAS SEEN VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. A LARGE PERFORATION, EXTENDING FROM THE SUBCLAVIAN, INNOMINATE, THROUGH THE SVC

  Patient problems: Cardiac Perforation; Great Vessel Perforation; Perforation of Vessels

  MAUDE report 20751410 ↗
• DeathNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION (LEAD FRACTURE). A RIGHT ATRIAL (RA) LEAD WAS PRESENT IN THE PATIENT AS WELL, BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE LEAD, WITH POLY SORB SUTURE USED AS WELL, TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, THE LEAD HIGH VOLTAGE CABLES BEGAN TO EXTERNALIZE; THEREFORE, THE DEVICE WAS UPSIZED TO A 13F TIGHTRAIL SUB-C, TO ACCOMMODATE THE DAMAGED LEAD. ONCE THE SUB-C HAD SUCCESSFULLY ADVANCED AND RAN OUT OF LENGTH, A 13F TIGHTRAIL (LONG) WAS USED. SEVERAL BINDING SITES WERE ENCOUNTERED WITHIN THE VASCULATURE, BUT PROGRESS WAS MADE TO APPROXIMATELY 1/3 OF THE WAY DOWN THE LEAD SECOND COIL. HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, CPR, ADMINISTRATION OF BLOOD PRODUCTS AND FLUIDS, STERNOTOMY, AND CELL SAVER. A SUPERIOR VENA CAVA (SVC)/RA JUNCTION PERFORATION WAS DISCOVERED AND REPAIRED. DESPITE REPAIR WITH APPROXIMATELY 45 MINUTES OF LIFE SAVING EFFORTS, THE PATIENT DID NOT SURVIVE. THIS REPORT CAPTURES THE 13F TIGHTRAIL IN US

  Patient problems: Cardiac Perforation; Great Vessel Perforation

  MAUDE report 20611531 ↗
• DeathOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD IMPLANTED IN 1990, AND AN RA AND RV LEAD, IMPLANTED IN 2019. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, THE RA AND RV LEADS (IMPLANTED IN 2019) WERE EXTRACTED SUCCESSFULLY. NEXT, UPSIZING TO A 16F GLIDELIGHT AND THEN SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, THE RV LEAD (IMPLANTED IN 1990) WAS REMOVED. THEN, USING THE 13F TIGHTRAIL ON THE REMAINING RA LEAD (IMPLANTED IN 1990), ADVANCEMENT WAS MADE THROUGH THE SUBCLAVIAN AND INNOMINATE REGIONS, AND PROGRESSED FARTHER THROUGH BINDING SITES IN THE SUPERIOR VENA CAVA (SVC). ONCE THROUGH THE BINDING, THE RA LEAD DISLODGED, AND THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, MEDICATIONS, AND STERNOTOMY. A 1 CM PERFORATION TO THE RIGHT ATRIUM WAS DISCOVERED AND REPAIRED (MDR #3007284006-2024-00204). HOWEVER, WHILE CLOSING THE PATIENT'S CHEST, A HEMATOMA AND TWO SMALL PERFORATIONS IN THE SVC WERE DETECTED (MDR #3007284006-2024-00205). ATTEMPTS WERE MADE TO REP

  Patient problems: Great Vessel Perforation

  MAUDE report 20411101 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV) LEADS (ONE ABANDONED AND ONE ACTIVE) DUE TO LEAD DAMAGE AND A REDUNDANT LEAD. SPECTRANETICS LLD #2 LEAD LOCKING DEVICES (LLD #2S) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION; HOWEVER, THE LLD #2 IN THE ABANDONED LEAD ADVANCED ONLY TO THE AREA OF LEAD DAMAGE AND BECAME STUCK, BUT WAS ABLE TO BE USED, DESPITE NOT BEING DEPLOYED. USING SPECTRANETICS DEVICES (16F GLIDELIGHT LASER SHEATH AND 13F TIGHTRAIL ROTATING DILATOR SHEATH), THE ACTIVE RV LEAD WAS SUCCESSFULLY REMOVED. THEN, WHILE WORKING TO REMOVE THE ABANDONED RV LEAD WITH USE OF THE 13F TIGHTRAIL, THE PATIENT'S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS. THE PATIENT HAD A CARDIAC ARREST (BLOOD COAGULATED IN A STRANGE WAY) AND A STERNOTOMY FOLLOWED; A PERFORATION IN THE SUPERIOR VENA CAVA (SVC) WAS DISCOVERED AND REPAIRED. THE ABANDONED RV LEAD WAS CUT (WITH THE LLD #2 BEING REMOVED IN ITS ENTIRETY), WITH THE LEAD REMNANT REMAINING IN THE PATIENT, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVE

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 20359715 ↗